K232475
- 510(k) number
- K232475
- Device name
- Disposable infusion set with needle
- Applicant
- Shandong Zhushi Pharmaceutical Group Co., Ltd. CN
- Product code
- FPA — Set, Administration, Intravascular
- Decision date
- 2024-05-10
- Date received
- 2023-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K232475.pdf
Official FDA record: K232475
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.